This guidance describes FDA’s current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix. Under this naming convention, the nonproprietary name designated for each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters. The suffix format described in this guidance is applicable to originator biological products, related biological products, and biosimilar products previously licensed and newly licensed under section 351(a) or 351(k) of the PHS Act. FDA is continuing to consider the appropriate suffix format for interchangeable products.
This naming convention will facilitate pharmacovigilance for originator biological products, related biological products, and biosimilar products containing related drug substances when other means to track a specific dispensed product are not readily accessible or available, as described in section IV.A of this guidance. Distinguishable nonproprietary names will also facilitate accurate identification of these biological products by health care practitioners and patients. Further, distinguishing suffixes should help minimize inadvertent substitution of any such products that have not been determined to be interchangeable. Application of the naming convention to biological products licensed under the PHS Act should (1) encourage routine use of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices and (2) avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway, as described in detail in this guidance.
This guidance provides information to industry, the health care community, other regulatory agencies, and the public on FDA’s rationale for this naming convention. It is also intended to assist applicants and license holders in proposing the suffix to be incorporated in the nonproprietary name (referred to throughout this guidance as the proper name) for an originator biological product, a related biological product, or a biosimilar product.